Numerous medical devices used for vascular dilation, calibration, suturing or perfusion are in existence. However, most devices are designed for providing a singular function. Designing a multipurpose medical device is a significant challenge in that the device must be cost effective to produce, reliable and the structures which provide each function must be complimentary rather than interfere with each other. Some existing devices do provide more than one function however none perform all of the functions that are accomplished by the present invention.
One example of a multipurpose device is the Fogarty.RTM. Flexible Calibrator manufactured by American Edwards Laboratories. This device is used as a dilator and calibrator, however it is not and can not be used for suturing or perfusion. Also, this device can only calibrate a single size, since the device has a uniform diameter. This is not cost effective since surgeons on average require 2.5 devices per patient per procedure to properly calibrate the size. At approximately $75 per device, which are single use only (i.e., disposed of after use in a patient), this is a significant cost. Another device which is sometimes used in place of the Fogarty.RTM. Flexible Calibrator is the metal olive tip probe. Although this device is reuseable, it is very traumatic to vessels as it is very hard and inflexible.
Other devices exist for performing singular functions. The Coronary Artery Occluder manufactured by DLP is a typical device that is used to occlude the coronary artery. This is done by inserting the device into the artery and suturing the device in place. Every 15 minutes the sutures and the device must be removed to allow for perfusion of fluids or blood to the artery. This is time consuming and must be performed by the surgeon.
The Fogarty.RTM. Bi-pass Shunt is used to bi-pass an artery from one end of a diseased segment to another in order to maintain blood flow. Catheter are known in the art for use as perfusion devices. On example of such a catheter is found in U.S. Pat. No. 5,364,344, which discloses a dual lumen catheter.
The lack of a multipurpose medical device that functions as a dilator, calibrator, occluder, suture guide and perfusion device is an important problem in the medical field. Currently, multiple devices must be used to perform these functions. This results in higher surgical costs since additional instruments must be used during surgery. Also, time is lost since a surgeon must switch from one instrument to another in order to perform these different functions, rather than smoothly transitioning from one function to the next with a single instrument. Additionally, time is lost every time the surgeon must remove an occluder and sutures to perfuse an artery and then re-insert the occluder and sutures. This means time that the surgeon must spend in the operating room and the patient is anesthetized. Switching from one instrument to another is also problematic in that the surgeons attention shifts from the hand off of the instrument from the nurse and away from the patient.
The present invention provides a multipurpose medical device that helps solves these problems by packaging a multitude of functions into a singular medical device. In particular, the present invention is intended to replace the Fogarty.RTM. Flexible Calibrator (or the metal olive tip probe), the DLP Coronary Artery Occluder, the Fogarty.RTM. Bi-pass Shunt and perfusion catheters with a singular device that provides these functions and more.